# K124014: Surefix Interspinous Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Jg Spine, LLC
- Decided: Aug 9, 2013 after 225 days
- Product code: PEK (Spinous Process Plate)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K990745 (1999). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100935: Lanx Spinal Fixation System, Lanx, Inc. (2010) Summary page 1.
- K101471: Axle Interspinous Fusion System, X-Spine Systems, Inc. (2010) Summary page 1.

## Indications for use
The SureFix Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (Ti-Si inclusive). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor. The SureFix Interspinous Fusion System is intended for use with bone graft material, and not for stand-alone use.

Source page: https://510kreport.com/device/K124014
Methodology: https://510kreport.com/methodology